Positive IMPACT trial results will likely lead to Provenge approval by the FDA in 1H10This morning, Dendreon Corporation (DNDN) announced results of the long-awaited pivotal phase III IMPACT study of Provenge in men with advanced prostate cancer. In the news release and the conference call, management disclosed that the phase III study met its primary endpoint of improving overall survival compared to a placebo. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of Provenge appeared to be consistent with prior trials.As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine. Previous two phase III studies ...

Shares of Dendreon Corp. (DNDN) jumped 38 percent last Friday and another 13% in early morning trading today. However, we don't see any clear rationale for the rally at this point of time. We believe investors are looking ahead to long-awaited data on the company's experimental Provenge vaccine to treat advanced prostate cancer, but we are cautious about the final results anticipated by the end of April. As a reminder, Dendreon's lead drug candidate Provenge is under phase III IMPACT confirmatory study for prostate cancer under a special protocol assessment (SPA) with the FDA. Provenge is a therapeutic vaccine.Previous two phase III studies generated mixed results. Study D9901 showed that Provenge approached, but did not meet its primary end point of showing a significant delay in time to disease progression (p=0.052, HR=1.4). However, Provenge showed a statistically significant median survival benefit (secondary endpoint) in ...